This is a complete re-write of VS Memo 800.210 “Minor Temperature Deviations of Biological Products”. It is intended to expand the ability of firms to make quality decisions regarding product release independent of CVB-IC. We encourage all firms to review the draft memo and offer comments. We are also available to assist with your review process. Please contact any EDGE partner if you should have questions.

Memo 800.210 “Minor Temperature Deviations of Biological Products”

https://www.aphis.usda.gov/animal_health/vet_biologics/publications/memo_800_210.pdf

Draft Memo No. 593 “Manufacturing Deviations Identified Prior to Marketing Release”

https://www.aphis.usda.gov/animal_health/vet_biologics/publications/DRAFT_593.pdf